Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in France.

📋 Description

• Collaborate with SAR colleagues to strategize, organize, compile, monitor, track, and submit regulatory documents promptly.

• May serve as a point of contact for reviewing translation of submission documents such as applications, synopses, informed consent forms (ICF), labels, etc.

• Provide local quality control of submission dossiers prior to their dispatch when necessary.

• Effectively communicate the status and action plans regarding submissions to the SAR Lead and relevant project team members.

• Identify potential risks and develop mitigation strategies.

• Whenever possible, cultivate professional relationships with both internal and external stakeholders to facilitate the swift submission and approval of regulatory dossiers.

• Manage the customization text for country-specific patient information sheets and consent forms.

• Oversee the maintenance of country-specific drug labeling information.

• Keep Country Intelligence Pages updated.

• Be knowledgeable of and adhere to Standard Operating Procedures (SOPs), ICH Good Clinical Practice (GCP), and applicable regulations.

• Stay updated on evolving regulatory legislative requirements and maintain a regulatory intelligence database.

• Provide guidance to the SAR project team on suitable regulatory strategies.

• Review and recommend modifications to all pertinent documentation, including labels, patient information sheets, diary cards, etc., to ensure compliance with ICH GCP and country-specific mandates.

• Deliver timely and relevant updates regarding changes in the regulatory landscape to the Regulatory Affairs department.

• Advise the Regulatory Affairs team on the interpretation of new legislation, guidance, and directives.

⛳️ Requirements

• A degree with a major focus in medical, biological, physical, health, pharmacy, or another relevant scientific field.

• A minimum of three years of experience in clinical research, particularly in site activation and/or regulatory functions within a Contract Research Organization (CRO).

• Candidates must possess substantial experience in the regulatory process at a local level and under the EU Clinical Trials Regulation (EU-CTR).

• Strong understanding of ICH GCP, relevant clinical research conduct guidelines, and country regulations.

• Fluency in the local language is essential; a working knowledge of English is also required.

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development opportunities

• Remote work options